Coronary Artery Endothelial Dysfunction With Drug Coated Balloons (NCT04901767) | Clinical Trial Compass
CompletedNot Applicable
Coronary Artery Endothelial Dysfunction With Drug Coated Balloons
United Kingdom14 participantsStarted 2021-03-23
Plain-language summary
Use of intracoronary acetylcholine to investigate endothelial function in coronary arteries treated with either drug coated balloon angioplasty of drug eluting stents.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 18 years or above.
* Been treated with percutaneous coronary intervention of either drug coated balloon or drug eluting stent
Exclusion Criteria:
* Any contraindications to administration of acetylcholine or GTN
* History of coronary vasospasm or spontaneous coronary artery dissection
* Significant medical, surgical or psychiatric disease that would affect subject safety or influence the study outcome according to physician's opinion
* Patients who received a combination of drug eluting stents and drug coated balloon to the same vessel
* Significant renal impairment (estimated glomerular filtration rate \<30mL/min/ 1.73m2
* Body mass index \>35 (may affect coronary artery diameter qualitative assessment)
* Symptomatic congestive cardiac failure
* Severe asthma
* Significant autoimmune inflammatory conditions (for example rheumatoid arthritis)
* Patients taking immunomodulating drugs (including Methotrexate, Ciclosporin, steroids)
* Previous heart transplant
* Relative Anaemia - Haemoglobin \<12g/dL in men and \<10g/dL in women
* Women of child bearing age with a positive pregnancy test
What they're measuring
1
Fractional change in coronary artery diameter and surface area within treated segment
Timeframe: 3-6 months
Trial details
NCT IDNCT04901767
SponsorNorfolk and Norwich University Hospitals NHS Foundation Trust